Oral compositions and related methods for reducing throat irritation

Abstract

The disclosure provides compositions configured for oral use, the compositions including at least one filler, water, a basic amine, and an organic acid, an alkali metal salt of an organic acid, or a combination thereof, wherein the organic acid has a log P value of from about 1.4 to about 8.0. At least a portion of the basic amine is associated with at least a portion of the organic acid or the alkali metal salt thereof. The association is in the form of a basic amine-organic acid salt, an ion pair between the basic amine and a conjugate base of the organic acid, or a combination of both. Further provided are methods for stabilizing a composition configured for oral use, for enhancing a predicted buccal absorption of a composition configured for oral use, and for reducing potential throat irritation associated with the use of compositions including a basic amine.

What is claimed is: 
     
         1 . A method of reducing throat irritation during use of a composition configured for placement in an oral cavity, the method comprising introducing the composition into the oral cavity, the oral composition comprising a basic amine and an organic acid, an alkali metal salt of an organic acid, or a combination thereof, wherein the organic acid has a log P value of from about 1.4 to about 8.0, and at least a portion of the basic amine is associated with at least a portion of the organic acid or the alkali metal salt thereof, the association in the form of a basic amine-organic acid salt, an ion pair between the basic amine and a conjugate base of the organic acid, or both. 
     
     
         2 . The method of  claim 1 , wherein the composition introduced into the oral cavity causes less throat irritation than a composition comprising the same amount of basic amine in the absence of the organic acid, the alkali metal salt of an organic acid, or a combination thereof. 
     
     
         3 . The method of  claim 1 , wherein the composition further comprises at least one filler and water. 
     
     
         4 . The method of  claim 1 , wherein the organic acid has a log P value of from about 1.4 to about 4.5. 
     
     
         5 . The method of  claim 1 , wherein the organic acid has a log P value of from about 2.5 to about 3.5. 
     
     
         6 . The method of  claim 1 , wherein the organic acid has a log P value of from about 4.5 to about 8.0, and wherein the composition further comprises a solubility enhancer. 
     
     
         7 . The method of  claim 6 , wherein the solubility enhancer is glycerol or propylene glycol. 
     
     
         8 . The method of  claim 1 , comprising from about 0.05, about 0.1, about 1, about 1.5, about 2, or about 5, to about 10, about 15, or about 20 molar equivalents of the organic acid, the alkali metal salt thereof, or the combination thereof, relative to the basic amine, calculated as the amine free base. 
     
     
         9 . The method of  claim 1 , comprising from about 2 to about 10 molar equivalents of the organic acid, the alkali metal salt thereof, or the combination thereof, relative to the basic amine, calculated as free base nicotine. 
     
     
         10 . The method of  claim 1 , wherein the organic acid is an alkyl carboxylic acid, an aryl carboxylic acid, an alkyl sulfonic acid, an aryl sulfonic acid, or a combination of any thereof. 
     
     
         11 . The method of  claim 1 , wherein the organic acid is octanoic acid, decanoic acid, benzoic acid, heptanesulfonic acid, or a combination thereof. 
     
     
         12 . The method of  claim 1 , wherein the organic acid is octanoic acid. 
     
     
         13 . The method of  claim 1 , wherein the alkali metal is sodium or potassium. 
     
     
         14 . The method of  claim 1 , comprising the organic acid and a sodium salt of the organic acid. 
     
     
         15 . The method of  claim 14 , wherein a ratio of the organic acid to the sodium salt of the organic acid is from about 0.1 to about 10. 
     
     
         16 . The method of  claim 1 , comprising benzoic acid and sodium benzoate, octanoic acid and sodium octanoate, decanoic acid and sodium decanoate, or a combination thereof. 
     
     
         17 . The method of  claim 1 , wherein the pH of the composition is from about 4.0 to about 9.5. 
     
     
         18 . The method of  claim 1 , wherein the pH of the composition is from about 4.5 to about 7. 
     
     
         19 . The method of  claim 1 , wherein the pH of the composition is from about 5.5 to about 7. 
     
     
         20 . The method of  claim 1 , wherein the pH of the composition is from about 4.0 to about 5.5. 
     
     
         21 . The method of  claim 1 , wherein the pH of the composition is from about 7.0 to about 9.5. 
     
     
         22 . The method of  claim 1 , wherein the basic amine is nicotine. 
     
     
         23 . The method of  claim 22 , wherein the nicotine is present in an amount of from about 0.001 to about 10% by weight of the composition, calculated as the free base and based on the total weight of the composition. 
     
     
         24 . The method of  claim 3 , wherein the at least one filler comprises a cellulose material. 
     
     
         25 . The method of  claim 24 , wherein the cellulose material comprises microcrystalline cellulose. 
     
     
         26 . The method of  claim 3 , wherein the at least one filler further comprises a cellulose derivative in an amount by weight of from about 2% to about 5%, based on the total weight of the composition. 
     
     
         27 . The method of  claim 26 , wherein the cellulose derivative is hydroxypropylcellulose. 
     
     
         28 . The method of  claim 3 , wherein the water is present in an amount from about 5 to about 50% by weight, based on the total weight of the composition. 
     
     
         29 . The method of  claim 3 , wherein:
 the at least one filler is present in an amount from about 60 to about 85% by weight, based on the total weight of the composition; and   the water is present in an amount from about 15 to about 20% by weight, based on the total weight of the composition.   
     
     
         30 . The method of  claim 1 , wherein the composition further comprises one or more active ingredients, one or more flavoring agents, one or more salts, one or more sweeteners, one or more binding agents, one or more humectants, one or more gums, a tobacco material, or combinations thereof. 
     
     
         31 . The method of  claim 1 , wherein the composition further comprises one or more active ingredients selected from the group consisting of nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, and terpenes. 
     
     
         32 . The method of  claim 1 , wherein the composition comprises no more than about 10% by weight of a tobacco material, excluding any nicotine component present, based on the total weight of the composition. 
     
     
         33 . The method of  claim 1 , wherein the composition is substantially free of tobacco material. 
     
     
         34 . The method of  claim 1 , further comprising enclosing the composition in a pouch to form a pouched product, the composition optionally being in a granular form.